CognIFied: protocol for a pilot randomised controlled trial of a culturally adapted, task-shifted compensatory cognitive training intervention for young adults with first-episode psychosis in Nigeria.

Abstract

Cognitive impairment is present in the majority of individuals with first-episode psychosis (FEP) and is a strong predictor of long-term functional disability. Despite this, evidence-based cognitive interventions are rarely available in routine mental healthcare in low-income and middle-income countries, where most young people with psychosis reside. This protocol describes the CognIFied study, a pilot randomised controlled trial evaluating the feasibility and acceptability of a culturally adapted, task-shifted compensatory cognitive training (CCT) intervention for young adults with FEP in Nigeria. CognIFied is a multicentre, assessor-blind, parallel-group pilot randomised controlled trial with an embedded mixed-methods process evaluation. The study will recruit 180 young adults aged 18-30 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-defined FEP (onset within the past 5 years) and objective cognitive impairment from three public psychiatric hospitals in Nigeria. Participants will be randomised 1:1 to receive either culturally adapted CCT or an active control condition, Enhanced Recreational Therapy. Both interventions comprise 12 weekly group sessions lasting 60-90 min. CCT is delivered by trained psychiatric social workers using a manualised curriculum co-designed with young people with lived experience. Primary outcomes assess feasibility (recruitment, retention, intervention adherence), acceptability (Client Satisfaction Questionnaire-8) and intervention fidelity. Secondary outcomes include preliminary signals of effectiveness on global cognitive functioning (Brief Assessment of Cognition in Schizophrenia) and functional capacity (University of California, San Diego [UCSD] Performance-Based Skills Assessment), assessed at baseline and at 3, 6 and 12 months. Quantitative analyses will be descriptive and exploratory, supplemented by qualitative inquiry guided by Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Consolidated Framework for Implementation Research frameworks and an exploratory economic evaluation. Ethical approval has been obtained from relevant institutional review boards. Findings will be disseminated through open-access publications, policy-focused stakeholder engagement and community dissemination co-led by a Youth Research Team. ISRCTN44794154.